Cytal® Wound Matrix and MicroMatrix® Wound Study

NCT ID: NCT03632954

Last Updated: 2021-05-11

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 37 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-12-11
• Study Completion Date: 2020-01-27

Brief Summary

This is an observational study to assess the safety and efficacy of MicroMatrix® alone or in combination with Cytal® Wound Matrix on primary measures of wound healing.

Detailed Description

A single-site, prospective, observational clinical study of Cytal® Wound Matrix alone or in combination with MicroMatrix® for the management of wounds. Up to 100 patients with multiple wound types including but not limited to, venous ulcers, diabetic foot ulcers, trauma wounds, and external surgical wounds will be treated either with Cytal® Wound Matrix alone or with Cytal® Wound Matrix and MicroMatrix® for wounds exceeding 3mm in depth. Wound healing efficacy, effect of treatment on patient-reported quality of life, complete wound management, wound-related adverse event, and wound pathology will be measured. The protocol defined patient follow-up is 12 months.

Conditions

Wounds

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

ACell Arm

Cytal® Wound Matrix and/or MicroMatrix®

Cytal® Wound Matrix 1-Layer is composed of porcine-derived extracellular matrix also known as urinary bladder matrix. It is intended for the management of a variety of wounds. The individual device is intended for one time use.

MicroMatrix® is composed of a porcine-derived extracellular matrix known as urinary bladder matrix and is intended for the management of a variety of wounds. The devices are supplied in particle form in masses up to 1000mg. It is intended for one-time use.

ACell Arm

Intervention Type: DEVICE

Cytal® Wound Matrix and/or MicroMatrix®

Interventions

ACell Arm

Cytal® Wound Matrix and/or MicroMatrix®

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Subject has at least one wound that the treating physician determines may be treated with Cytal® with or without MicroMatrix®.

2. Subject is at least 21 years of age.

3. Subject is willing and able to adhere to protocol requirements and agrees to participate in the study program and comply with the study follow-up regimen.

4. Subject or legal representative is willing to provide informed consent.

5. For females of reproductive potential, confirmed negative urine pregnancy test at enrollment.

Exclusion Criteria

1. Allergy or hypersensitivity to materials in porcine-based study products (per subject report) or personal preference.

2. Subject report of concurrent participation in another clinical trial that involves an investigational drug or device that would interfere with this study.

3. The subject has any condition that, in the Investigator's opinion, would warrant exclusion from the study or prevent the subject from completing the study.

4. The subject's wound shows evidence of infection as determined by the Principal Investigator (which may be indicated by the presence of: elevated WBC, pus, moderate or greater discharge, abnormal odor, or acute osteomyelitis).

5. Wound with exposed organs or hardware.

6. Wound with burn etiology.

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Winthrop University Hospital

OTHER

Sponsor Role: collaborator

Integra LifeSciences Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Allison Matthews

Role: STUDY_CHAIR

Integra LifeSciences Corporation

Locations

NYU Winthrop Hospital

Long Island City, New York, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

CR2017-012

Identifier Type: -

Identifier Source: org_study_id